The U.S. Food and Drug Administration (FDA) is requiring safety-labeling changes for all opioid pain medications to more clearly communicate the risks associated with long-term use.
Updated labels will be required to:
- Summarize study results showing the estimated risks of addiction, misuse, and overdose during long-term use;
- Provide additional warnings that higher doses come with greater risks;
- Remove language that could be misinterpreted to support using opioid pain medications indefinitely;
- Reinforce that long-acting or extended-release opioids should only be considered when other treatments are inadequate;
- Warn against stopping opioids suddenly in patients who may be physically dependent; and
- Include additional information on opioid‑related risks and complications, including medications that can reverse opioid exposure, toxic leukoencephalopathy, opioid‑associated esophageal disorders, and the increased dangers of combining opioids with other substances.
Learn more.